TB 020005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836559009733), received between Jan 6, 2017 and Apr 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Pacing” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K861403); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2018No Pacing; No Pacing

  IT WAS REPORTED THAT THE PACEMAKER PROBE DID NOT STIMULATE AND NO IMPULSES WERE GIVEN. EVEN AFTER TRYING DIFFERENT CHANGES IN POSITION, NO ACTION COULD BE REGISTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED AS YET.

  Patient problems: No Information

  MAUDE report 7466499 ↗
• MalfunctionJan 6, 2017No Pacing; No Pacing

  THE TB WAS PLACED ON (B)(6) 2016. STIMULATION WAS POSSIBLE AFTER ELECTRODE PLACEMENT. THEN BROKE OFF AFTER A FEW HOURS. HAVE TRIED TO REPOSITION THE ELECTRODE, BUT THIS DID NOT GIVE ANY IMPROVEMENT. THE PATIENT WAS THEN IMPLANTED WITH A PERMANENT PACEMAKER. NO PERMANENT HEALTH DAMAGE OCCURRED FOR THE PATIENT. WITH THE OSCOR DEVICE WAS COMBINED A PACE 100.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6229409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K861403. One submission often covers many models, so check the product and lot details in each record.

• Z-0391-2019 · Sep 26, 2018 · Terminated
  TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray